A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Florinef Indications, Dosage, Storage, Stability - Fludrocortisone Acetate
Florinef Indications, Dosage, Storage, Stability - Fludrocortisone Acetate
INDICATIONS AND USAGE
Florinef Acetate is indicated as partial replacement therapy
for primary and secondary adrenocortical insufficiency in Addison’s disease
and for the treatment of salt-losing adrenogenital syndrome.
DOSAGE AND ADMINISTRATION
Dosage depends on the severity of the disease and the response
of the patient. Patients should be continually monitored for signs that indicate
dosage adjustment is necessary, such as remissions or exacerbations of the disease
and stress (surgery, infection, trauma) (see WARNINGS
and PRECAUTIONS, General).
Addison’s Disease
In Addison’s disease, the combination of Florinef Acetate (Fludrocortisone
Acetate Tablets USP) with a glucocorticoid such as hydrocortisone or cortisone
provides substitution therapy approximating normal adrenal activity with minimal
risks of unwanted effects.
The usual dose is 0.1 mg of Florinef Acetate daily, although
dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed.
In the event transient hypertension develops as a consequence of therapy, the
dose should be reduced to 0.05 mg daily. Florinef Acetate is preferably administered
in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone
(10 mg to 30 mg daily in divided doses). Salt-Losing Adrenogenital Syndrome
The recommended dosage for treating the salt-losing adrenogenital
syndrome is 0.1 mg to 0.2 mg of Florinef Acetate daily.
HOW SUPPLIED
Florinef Acetate Tablets (Fludrocortisone Acetate Tablets USP),
0.1 mg/tablet: white, round, biconvex, scored tablets in bottles of 100 (NDC
61570-190-01); identification no. 429.
Storage
Store at room temperature; avoid excessive heat.
Prescribing Information as of July 2003.
Distributed by: Monarch Pharmaceuticals, Inc.,
Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.)
Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08540 USA
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